MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; TIP COVER ACCESSORY

Model Number 400180

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2022

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted radical cystectomy with other urinary diversion surgical procedure, the monopolar curved scissors (mcs) tip cover fell off the instrument and inside the patient's body.The mcs tip cover was retrieved and replaced with a new one; however, the same issue occurred again.The customer replaced the mcs instrument with a backup and the mcs tip cover no longer fell off the instrument.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the operating room nurse and obtained the following additional information: the procedure was a total cystectomy perform on (b)(6) 2022.After the first mcs tip cover fell inside the patient's body, the surgeon quickly retrieved it with an assistant forceps.Then, the user installed a new mcs tip cover on the mcs instrument outside of the patient's body but the mcs tip cover slipped off easily.The mcs tip cover appeared to be installed properly with no visible orange surface.The mcs tip cover was not installed beyond the orange surface that would cause a bulge over the shaft.No installation tool was used.The mcs instrument was exchanged out with a backup.There was no functional issue with the mcs instrument.The procedure continued without further problems.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the monopolar curved scissors (mcs) instrument and completed the failure analysis investigation.Both mcs tip covers (part# 400180) were discarded by the customer and will not be returned.Failure analysis was not able to verify the reported event.An in-house mcs tip cover was installed on the instrument and it covered the entire distal portion of the tube extension.The instrument was placed through a cannula and cannula seal, and was driven on an in-house system.The mcs tip cover did not fall off or appear to be loose, and remained on the tube extension during testing.Upon visual inspection, there was no physical damage at the distal wrist.There was no problem detected.A review of the device logs for the mcs instrument (part# 470179-19 | lot/serial# (b)(4)) associated with this event has been performed.Per this review of the logs, the mcs was last used on (b)(6) 2022 via system serial# (b)(4).There were 3 uses remaining after this last usage.This last usage of the device per the log review matches the reported event date, indicating that the instrument was not used after the date of the reported event.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or video clip for the reported event was available for review.A system log review was performed, but no errors related to this event would exist in the logs.This complaint is considered a reportable event due to the following conclusion: it was alleged that the monopolar curved scissors (mcs) tip cover fell inside the patient during a da vinci assisted procedure.The mcs tip cover was retrieved during the same procedure with no patient injury.At this time it is unknown what caused the mcs tip cover to fall.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.

• Brand Name: DA VINCI
• Type of Device: TIP COVER ACCESSORY
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 13985085
• MDR Text Key: 293611075
• Report Number: 2955842-2022-10854
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400180
• Device Catalogue Number: 400180
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/02/2022
• Initial Date FDA Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES